Implance Dental Implant System is indicated to use for surgical placement in the upper and lower jaw arches, to provide a root form means for single and multiple units' prosthetic appliance attachment to restore a patient's chewing function.

Implance Dental Implant can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading.

Immediate loading is restricted to the anterior mandible based on four splinted-interforminal placed implants.

Implance Dental Abutment System is used with a dental implant to prosthetic restorations such as crown, bridge and overdentures in partially or fully edentulous patients. Octa Abutment models that contain an abutment post height less than 4 mm are indicated only for multi-unit loading, such as bridge or overdenture.

Device Description

The Implance Dental Implant System consists of titanium alloy dental implants and titanium closing screws. The Implance Dental Implants are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore the patient's chewing function. The surface of the implant is sand-blasted with a resorbable blast media (RBM). The provided closing screw covers the Implance Dental Implant during the healing process.

The Implance Dental Implants (Table 1) are either bone level or tissue level type implants and are available in multiple designs. Bone Level Implants primarily contact bone, whereas the Tissue Level implant contacts bone and tissue along the cuff portion of the dental implant.

The Implance Dental Abutment System (Table 2), consisting of titanium temporary and final abutments and screws, provides the link between the Implance Dental Implant and the prosthesis that forms the superstructure and allows chewing. Final, permanent abutments are available in multiple designs and range in diameter from 2.9 mm to 6.5 mm; cuff heights of 0.5 mm to 5 mm and lengths of 7 mm to 16.4 mm.

AI/ML Overview

This document describes the premarket notification (510(k)) for the Implance Dental Implant System and Implance Dental Abutment System. The focus of the provided text is on demonstrating substantial equivalence to predicate devices, rather than establishing new acceptance criteria or conducting a study to prove a device meets new acceptance criteria. The performance data presented are primarily non-clinical and aim to show that the new device performs comparably to the predicate devices and meets existing standards.

Therefore, the requested information elements related to user studies, sample sizes for test sets, expert-established ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, and training set details are not applicable to this type of device submission as described.

However, I can extract the acceptance criteria (standards and guidance documents used) and the reported device performance based on the non-clinical testing conducted to support substantial equivalence.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for demonstrating substantial equivalence are based on established FDA guidance and international standards for dental implants and abutments. The device's performance is demonstrated through non-clinical testing to show compliance with these standards and comparability to predicate devices.

Table 1: Acceptance Criteria and Reported Device Performance

Category / Test	Acceptance Criteria (Reference Standard/Guidance)	Reported Device Performance
Premarket Notification (General)	Substantial Equivalence to Legally Marketed Predicate Devices (pre-May 28, 1976 or reclassified)	Determined to be substantially equivalent to the Dentis Dental Implant System (K073486) and Klockner Dental implant abutment (K122988) based on intended use, material composition, basic design, dimensions, and surface treatment.
Material Standards (Implants)	ASTM F-67 (Titanium Grade 4) & ASTM F-136-13 (Titanium Grade 5)	Implants made of Titanium Grade 4 & 5, meeting referenced ASTM standards.
Material Standards (Abutments)	Titanium Grade 5 (Bone Level 3.3 & 3.7 mm implants), Titanium Grade 4 ASTM F-67 (Bone Level 4.3; 4.8; 5.5 mm and Tissue Level implants), Screw: Titanium Grade 5 ASTM F136	Abutments made of specified Titanium grades, meeting referenced ASTM standards.
Biocompatibility	- ISO 10993-5:2009 (Cytotoxicity)- ISO 10993-10:2010 (Sensitization, Irritation/Intracutaneous)- ISO 10993-11:2006 (Acute systemic toxicity, Subchronic toxicity)- ISO 10993-3:2003 (Genotoxicity)- ISO 10993-6:2007 (Implantation)- FDA Class II Special Controls Guidance Document (Root-form Endosseous Dental Implants and Endosseous Dental Abutments)	All biocompatibility tests found the materials used in the Implance Dental Implant & Implance Dental Abutment Systems to be biocompatible.
Surface Treatment Analysis	Homogeneity of surface and elemental analysis (general acceptance for RBM surfaces)	SEM analysis of RBM surface found homogeneous surface; Energy-dispersive X-ray spectroscopy provided elemental analysis and chemical characterization after washing.
Sterilization Validation (Implants)	- SAL of 10⁻⁶- Packaging sufficient to maintain sterility for 5-year shelf life	Gamma ray sterilization validated to ensure a SAL of 10⁻⁶. Packaging tests (Adhesion Strength Control Force (Seal Strength), Package Tightness (Seal Leak) Test, and Sterility Test) confirmed maintenance of sterility for a 5-year shelf life.
Sterilization Validation (Abutments)	- SAL of 10⁻⁶ (for end-user performed sterilization)	Provided non-sterile. Sterilization parameters for end-user (steam gravity sterilization method) validated to achieve a SAL of 10⁻⁶.
Mechanical Testing (Dynamic Fatigue)	ISO 14801 Dentistry-Implants-Dynamic fatigue test for Endosseous dental implants- FDA Class II Special Controls Guidance Document	Fatigue testing on worst-case bone level implant/abutment combinations found results consistent with FDA Class II Special Controls guidance and ISO 14801, demonstrating substantially equivalent performance.

Detailed Information on the Study (as applicable to this 510(k) submission):

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This document describes non-clinical performance testing (e.g., in-vitro biocompatibility, materials characterization, mechanical fatigue tests). The concept of a "test set" and "data provenance" as typically applied to human clinical studies or AI algorithm evaluation is not directly relevant here. The "samples" would refer to the physical devices or materials subjected to laboratory tests. Specific sample sizes for each non-clinical test (e.g., number of implants for fatigue testing, number of material samples for biocompatibility) are not detailed in this summary but would be part of the full testing reports submitted to the FDA. The tests would have been performed in a laboratory setting, likely in the country of origin of the manufacturer (Turkey) or by contracted testing facilities. These are prospective non-clinical tests.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. "Ground truth" established by experts is typically for diagnostic devices or AI algorithms that interpret medical data. This submission focuses on the safety and effectiveness of a physical medical device (dental implants and abutments) through non-clinical performance testing against established standards. Device specifications and test methodologies are determined by engineering and scientific standards, not expert interpretation of a "test set" in the context of clinical outcomes.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for a non-clinical device submission. Adjudication methods are used in clinical trials or studies to resolve discrepancies in expert interpretation of data.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is a submission for a physical dental implant system, not an AI-assisted diagnostic or therapeutic device that involves human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical medical implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the context of diagnostic "ground truth." For this device, "ground truth" means demonstrating that the physical properties and performance characteristics of the device meet established engineering and biocompatibility standards (e.g., ISO 14801 for fatigue, ISO 10993 for biocompatibility) and are comparable to predicate devices. This is achieved through objective, quantitative measurements derived from laboratory testing, rather than subjective expert consensus or clinical outcomes data for a "ground truth" label.
The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a training set.
How the ground truth for the training set was established:
- Not applicable. This is not an AI/machine learning device.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around a central emblem. The emblem consists of a stylized representation of three human profiles facing to the right, stacked one behind the other, with flowing lines beneath them.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 12, 2016

AGS Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti. % H. Semih Oktay, Ph.D. President CardioMed Device Consultants, LLC 5523 Research Park Drive, Suite 205 Baltimore, Maryland 21228

Re: K160221

Trade/Device Name: Implance Dental Implant System, Implance Dental Abutment System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: August 9, 2016 Received: August 10, 2016

Dear H. Semih Oktay:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K160221

R10021

Device Name Implance Dental Implant System Implance Dental Abutment System

Indications for Use (Describe)

Immediate loading is restricted to the anterior mandible based on four splinted-interforminal placed implants.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(K) SUMMARY

I. SUBMITTER

AGS Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti. Mehmet Afkan Sok. No: 57 Kat: 1, 34718 Kosuyolu-Kadikoy Istanbul, TURKEY Phone: 00902165460078 Fax: 00902165460079

US Consultant: Semih Oktay 5523 Research Park Drive, Suite 205 Baltimore, MD 21228 Phone: (410) 674-2060 Email: soktay@cardiomedllc.com

Date of Summary

September 7, 2016

II. DEVICE

Proprietary name	Implance Dental Implant SystemImplance Dental Abutment System
Common name	Endosseous Dental Implant & Abutments
Classification name	21 CFR 872.3640 Endosseous Dental implant
Regulatory Class	II
Product Codes	DZE (Primary Product Code), NHA

III. PREDICATE DEVICE

Primary Predicate Device:	Dentis Dental Device - K073486
Predicate Device:	Klockner Dental implant abutment - K122988

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IV DEVICE DESCRIPTION

Feature	Bone Level	Tissue Level
Connection	Platform	Platform
Connection	Internal	Internal
Connection	Hexagonal	Octagonal
Diameters (mm)	3.3; 3.7; 4.3; 4.8; 5.5	3.7; 4.3; 4.8 ; 5.5
Length (mm)	8, 10, 12, 14	8, 10, 12, 14

Table 1 Implance Dental Implant System Specifications

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Table 2 Implance Dental Abutment Types

GENERAL SPECIALTIES
Name	Type	Patient specific customization
COUPLE ABUTMENT	Cement-retainedFinal-typeScrew Required	Yes
ANGLED ABUTMENTBONE LEVEL	Cement-retainedFinal-typeScrew Required	No
SOLID ABUTMENT	Cement-retainedFinal-type	No
O-RING ABUTMENT	attachment-retained Final-type	No
MULTI ABUTMENT	Cement-retainedFinal-typeScrew Required	Yes
OCTA ABUTMENT	Attachment andScrew-retainedFinal-type	No
SYNOCTA ABUTMENTTISSUE LEVEL	Cement-retainedFinal-typeScrew Required	Yes
HEALING ABUTMENT	temporary	No

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Table 3 Implance Dental Abutment Sizes

Tissue level / Bone level	Platform Diameter (mm)	Cuff height (mm)	Length (mm)	Implant connection	Raw material
Bone Level (for Ø 3.3mm implants)	3.70	2.50	7.00	conic internal connection	Ti Gr 5
Bone Level (for Ø 3.3mm implants)	3.70	3.50	8.00
Bone Level (for Ø 3.3mm implants)	3.70	5.00	9.50
Bone Level (for Ø 3.3mm implants)	3.70	7.00	11.50
Bone level (for Ø 3.7,4.3, 4.8, 5.5 mmimplants)	4.5 - 5.5 -6.5	1.00	9.50	conic internal connection	Ti Gr 5
		2.00	10.50
		3.00	11.50
		4.00	12.50
		5.00	13.50
Tissue level (for Ø3.7, 4.3, 4.8mmimplants)	5.20	3.00	7.40	conic internal connection	Ti Gr 4
	5.20	4.00	8.40
	5.20	5.50	9.90
Tissue level (for Ø5.5mm implants)	6.40	3.00	7.40	conic internal connection	Ti Gr 4
	6.40	4.00	8.40
	6.40	5.50	9.90
Bone Level (for3.3mm implants)	3.70	1.00	11.50	conic internal connection	Ti Gr 5
	3.70	2.00	12.50
	3.70	3.00	13.50
	3.70	4.00	14.50
	3.70	5.00	15.50
Bone Level (for Ø3.7, 4.3, 4.8, 5.5 mmimplants)	4.5 - 5.5 -6.5	1.00	12.40	conic internal connection	Ti Gr 5
		2.00	13.40
		3.00	14.40
		4.00	15.40
		5.00	16.40
Tissue level (for Ø3.7, 4.3, 4.8mmimplants)	3.50	--	9.00	conic internal connection	Ti Gr 4
	3.50	--	10.50
	3.50	--	12.00
Tissue level (for Ø5.5mm implants)	4.30	--	9.00	conic internal connection	Ti Gr 4
	4.30	--	10.50
	4.30	--	12.00

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Bone Level (for Ø 3.3mm implants)				3.70	1.00	8.50	conic hexagonalinternal connection(Ø 2.1mm hex)
				3.70	2.00	9.50
				3.70	3.00	10.50
				3.70	4.00	11.50
				3.70	5.00	12.50
Bone level (for Ø 3.7, 4.3, 4.8, 5.5 mm implants)	4.5 - 5.5 - 6.5			1.00	8.90	conic hexagonalinternal connection(Ø 2.495mm hex)	Ti Gr 5
				2.00	9.90
				3.00	10.90
Bone level Non Hex(for Ø 3.3mm implants)			4.00	11.90
			5.00	12.90
			3.70	1.00	8.50	conic non-hexagonalinternal connection	Ti Gr 5
			3.70	2.00	9.50
			3.70	3.00	10.50
		3.70	4.00	11.50
		3.70	5.00	12.50
Bone level Non Hex(for Ø 3.7, 4.3, 4.8, 5.5 mm implants)	4.5 - 5.5 - 6.5			1.00	8.70	conic non-hexagonalinternal connection	Ti Gr 5
				2.00	9.70
				3.00	10.70
				4.00	11.70
				5.00	12.70
Tissue level (for Ø 3.7, 4.3, 4.8mm implants)			5.20	1.00	8.75	conic octagonalinternal connection(Ø 3.095mm octa)	Ti Gr 4
			5.20	2.00	9.75
			5.20	3.00	10.75
			5.20	4.00	11.75
Tissue level (for Ø 5.5mm implants)			6.40	1.00	8.75	conic octagonalinternal connection(Ø 3.095mm octa)	Ti Gr 4
			6.40	2.00	9.75
			6.40	3.00	10.75
			6.40	4.00	11.75
Tissue level non-octa(for Ø 3.7, 4.3, 4.8mm implants)			5.20	1.00	8.75	non-octagonalinternal connection	Ti Gr 4
			5.20	2.00	9.75
			5.20	3.00	10.75
			5.20	4.00	11.75
Tissue level non-octa(for Ø 5.5mm implants)			6.40	1.00	8.75	non-octagonalinternal connection	Ti Gr 4
			6.40	2.00	9.75
			6.40	3.00	10.75
			6.40	4.00	11.75

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MULTI ABUTMENTS	Bone level (for Ø 3.3mm implants)	3.70	1.00	14.50	conic hexagonal internal connection (Ø 2.1mm hex)	Ti Gr 5
	Bone level (for Ø 3.7, 4.3, 4.8, 5.5 mm implants)	4.50	1.00	15.63	conic hexagonal internal connection (Ø 2.495mm hex)	Ti Gr 5
		5.50	1.00	15.63
	Bone level- Non hex (for Ø 3.3mm implants)	3.70	1.00	14.50	conic non-hexagonal internal connection	Ti Gr 5
	Bone level- Non hex (for Ø 3.7, 4.3, 4.8, 5.5 mm implants)	4.50	1.00	15.63	conic non-hexagonal internal connection	Ti Gr 5
		5.50	1.00	15.63
	Tissue level	5.20 --		13.50	conic octagonal internal connection (Ø 3.095mm octa)	Ti Gr 4
	Tissue level-Non octa	5.20 --		13.50	conic non-octagonal internal connection	Ti Gr 4
OCTA ABUTMENTS	Bone level (for Ø 3.3mm implants)	4.80	1.00	8.65	conic hex internal connection (Ø 2.1mm hex)	Ti Gr 5
		4.80	2.00	9.65
		4.80	3.00	10.65
		4.80	4.00	11.65
		4.80	5.00	12.65
	Bone level (for Ø 3.7, 4.3, 4.8, 5.5 mm implants)	4.80	1.00	9.10	conic hex internal connection (Ø 2.495mm hex)	Ti Gr 5
		4.80	2.00	10.10
		4.80	3.00	11.10
		4.80	4.00	12.10
		4.80	5.00	13.10
	Tissue level	3.50 --		7.00	conic octa internal connection (Ø 3.095mm octa)	Ti Gr 4
SYNOCТА ABUTMENT	Tissue level	3.50 --		8.80	conic octagonal internal connection (Ø 3.095mm octa)	Ti Gr 4
	Tissue level-Non octa	3.50 --		8.80	conic non-octagonal internal connection	Ti Gr 4
O-RING ABUTMENTS	Bone level (for Ø3.3mm implants)	2.903.703.70	0.502.004.00	9.5011.1013.10	conic internalconnection	Ti Gr 5
	Bone level (for Ø 3.7,4.3, 4.8, 5.5 mmimplants)	3.424.504.50	0.502.004.00	10.1011.6013.60	conic internalconnection	Ti Gr 5
	Tissue level	3.503.503.50	0.502.004.00	9.1011.1013.10	conic internalconnection	Ti Gr 4

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Bone level	PlatformDiameter(mm)	Cuffheight(mm)	Length(mm)	Angle	Implant connection	Rawmaterial
Bone level (for Ø3.3mm implants)	3.70	1.00	8.50	15°	conic hexagonalinternal connection(Ø 2.1mm hex)	Ti Gr 5
	3.70	2.00	9.50	15°
	3.70	4.00	11.50	15°
	4.50	2.00	10.59	15°
	4.50	2.00	10.95	25°
	4.50	4.00	12.59	15°
	4.50	4.00	12.95	25°
Bone level (for Ø 3.7,4.3, 4.8, 5.5 mmimplants)	5.50	2.00	10.58	15°	conic hexagonalinternal connection(Ø 2.495mm hex)	Ti Gr 5
	5.50	2.00	11.06	25°
	5.50	4.00	12.58	15°
	5.50	4.00	13.06	25°
	6.50	2.00	10.57	15°
	6.50	2.00	11.13	25°
	6.50	4.00	12.57	15°
	6.50	4.00	13.13	25°
Bone level Non Hex(for Ø 3.3mmimplants)	3.70	1.00	8.50	15°	conic non-hexagonalinternal connection	Ti Gr 5
	3.70	2.00	9.50	15°
	3.70	4.00	11.50	15°
Bone level Non Hex(for Ø 3.7, 4.3, 4.8,5.5 mm implants)	4.50	2.00	10.38	15°		Ti Gr 5
	4.50	2.00	10.75	25°
	4.50	4.00	12.38	15°
	4.50	4.00	12.75	25°
	5.50	2.00	10.38	15°	conic non-hexagonalinternal connection
	5.50	2.00	10.86	25°
	5.50	4.00	12.38	15°
	5.50	4.00	12.86	25°
	6.50	2.00	10.37	15°
	6.50	2.00	10.93	25°
	6.50	4.00	12.37	15°
	6.50	4.00	12.93	25°

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V. INDICATIONS FOR USE

Immediate loading is restricted to the anterior mandible based on four splinted-interforminal placed implants.

Implance Dental Abutment System is used with a dental implant to provide support to prosthetic restorations such as crown, bridge and overdentures in partially or fully edentulous patients. Octa Abutment models that contain an abutment post height less than 4 mm are indicated only for multi-unit loading, such as a bridge or overdenture.

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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Technological characteristics of the Implance Dental Implant and Implance Dental Abutment Systems are compared with the predicate devices in the following tables.

Table 4 Implance Dental Implant System Substantial Equivalence Comparison
	Implance Dental Implant System	Primary PredicateDentis Dental Implants System
510k #	K160221	K073486
Indication	Indicated to use for surgical placement inthe upper and lower jaw arches, to providea root form means for single and multipleunits' prosthetic appliance attachment torestore a patient's chewing function.Implance can be placed with aconventional two stage surgical processwith an option for transmucosal healing orthey can be placed in a single stagesurgical process for immediate loading.Immediate loading is restricted to theanterior mandible based on four splintelinterforminal placed implants.	Indicated for use for surgical placement inthe upper and lower jaw arches to provide aroot form means for single or multiple unitsprosthetic appliance attachment to restore apatients chewing function. Implants can beplaced with a conventional two stagesurgical process with an option for transmucosal Healing or they can be placed in asingle stage surgical process for immediateloading. Immediate loading is restricted tothe anterior mandible based on four splintelinterforminal placed implants and notindicated for single unsplinted implants.
SystemComponents	Dental implant and closing screw	Implant Fixtures, Protective Cap, andImplant System Surgery Tray
Design	Threaded root-form bone or tissue levelimplant with hybrid and straight designsand Morse taper internal hexagon orinternal octagonal abutment interface	Threaded, root-form implant design withMorse taper internal, external andsubmerged abutment interface
Implant Size(mm)	Length8, 10, 12, 14	Diameter3.3, 3.7, 4.3,4.8, 5.5
	Length7-14	Diameter3.5, 3.7, 4.1, 4.3,4.8, 5.5, 6.0
Materials	Titanium grade 4 & 5	Titanium and its alloys
Surfacetreatment	RBM surface treatment	RBM surface treatment
Sterilization	Gamma	Gamma
Standard forTitanium	ASTM F-67 &ASTM F-136-13	ASTM F-67ASTM F-136

	Table 4 Implance Dental Implant System Substantial Equivalence Comparison

구

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Table 5 Implance Dental Abutment System Substantial Equivalence Comparison
	Implance Dental Abutment System	Klockner Dental implant abutment
510(k) #	K160221	K122988
Indication	Implance Dental Abutment System is usedwith a dental implant to provide support toprosthetic restorations such as crown, bridgeand overdentures in partially or fullyedentulous patients. Octa Abutment modelsthat contain an abutment post height lessthan 4 mm are indicated only for multi-unitloading, such as a bridge or overdenture.	Klockner Dental Abutments areintended to be placed into dentalimplants to provide support forprosthetic reconstructions such ascrowns, bridges or overdentures. TheKlockner Dental Implant Abutmentsinclude healing caps, protective caps,temporary abutments, angledabutments, straight abutments, andoverdentures. All abutments areintended to be used with the KlocknerDental Implant Systems, Models:Essential EC, Essential ES, EssentialECK, Essential EC 1.5, SK2and NK2.
Material	Titanium Grade 5 (Bone Level 3,3 & 3.7 mmimplants)Titanium Grade 4 ASTM F-67 (Bone Level4,3; 4,8; 5,5 mm implants)Titanium Grade 4 ASTM F-67 (Tissue Level)Screw: Titanium Grade 5 ASTM F136	Titanium cpTitanium alloyTitanium cp +PMMATitanium Alloy + POM C
Design	Temporary Abutment design with attachedconic internal connectionFinal Abutment designs:Solid with cemented connectionCouple, Bone Level Angled (15°, 25°), Multiand Synocta with cement and screw (conic,conic hexagonal, or conic octagonal)connection Octa with attached internal &external (conic hexagonal or octagonal)connectionO-ring with attached conic internalconnection	Temporary Abutment designWith internal octagonal connectionFinal Abutment designs:Angled (17°, 22°, 30°) with internaloctagonal and external hexagonalscrew connectionStraight with internal octagonalscrew connectionOverdenture abutment with ballconnection
Sterilization	Provided non-sterile	Provided non-sterile

Table 5 Implance Dental Abutment System Substantial Equivalence Comparison

The Implance Dental Implant System is the same or similar to the primary predicate Dentis Dental Implant System with respect to indication for use, design, material composition and surface treatment. The proposed devices have more limited indications for use than the primary predicate that does not alter the intended use for demonstration of substantial equivalence. With respect to available sizes, the Implance Dental Implant System includes a slightly smaller diameter than the predicate. The slight reduction in diameter size does not change the intended anatomical location, and the non-clinical mechanical testing provided demonstrates substantially equivalent performance.

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The Implance Dental Abutment System is the same or similar with respect to indication for use, material composition and basic design features as the predicate Klockner Dental Implant Abutments. The Implance Dental Abutment System differs from the predicate with additional abutment designs.

Non-clinical performance testing consistent with the FDA's Class II Special Controls guidance document and ISO 14801 support the substantial equivalence of the Implance Dental Implant System and the Implance Dental Abutment System.

VII. PERFORMANCE DATA

Performance testing of the Implance Dental Implance Dental Abutment followed the FDA guidance Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments.

Biocompatibility

Cytotoxicity (in vitro) ISO 10993-5:2009 ●
Sensitization- ISO 10993-10:2010 ●
. Irritation/ Intracutaneous - ISO 10993-10:2010
Acute systemic toxicity- ISO 10993-11:2006 ●
. Subchronic toxicity- ISO 10993-11:2006
Genotoxicity- ISO 10993-3:2003 ●
Implantation- ISO 10993-6:2007 .

Biocompatibility testing found the materials used in the Implance Dental Implant & Implance Dental Abutment Systems are biocompatible.

Surface Treatment Analysis

The Implance Dental Implant surface undergoes a RBM treatment using calcium phosphate micro particles. SEM analysis of the RBM surface found that the surface of the Implance Dental Implant was homogeneous. Energy-dispersive X-ray spectroscopy provided elemental analysis and chemical characterization of the RBM surface after washing.

Sterilization Validation

Implance Dental Implants are sterilized using a gamma ray sterilization process that has been validated to ensure a SAL of 10°. The Implance Dental Abutment System is provided non-sterile. Sterilization of the dental abutment system is performed by the end-user following parameters used in a validated steam gravity sterilization method that achieves a SAL of 106. The Implance Dental Implants provided sterile propose a 5-year shelf life date. The following tests were performed to show the packaging was sufficient to maintain

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sterility of the dental implants over the 5-year shelf life: Adhesion Strength Control Force (Seal Strength), Package Tightness (Seal Leak) Test, and Sterility Test.

Mechanical Testing

Fatigue testing on the worst case bone level Implance Dental Implant with the worst case Implance Dental Abutment was conducted in accordance with the ISO 14801 Dentistry-Implants-Dynamic fatigue test for Endosseous dental implants. Results of the fatigue testing found that the worst case (bone level) dental implant/abutment combinations were consistent with FDA Class II Special Controls guidance and ISO 14801.

VIII. CONCLUSION

The Implance Dental Implance Dental Abutment System have the same or similar intended use, material composition, basic design, dimensions and surface treatment. Based on an a comparative assessment with the predicate devices, and the performance test data, the Implance Dental Implance Dental Abutment Systems are determined to be substantially equivalent to the predicate devices.

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.